For US healthcare professionals only.
For US healthcare professionals only.

Important Safety Information:

CONTRAINDICATIONS: ELOCTATE® is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products. View more


ELOCTATE®—powered
by Fc Fusion

ELOCTATE®—
powered by Fc
Fusion

Extended Half-life

With Fc Fusion, ELOCTATE stays in circulation 1.5x longer than ADVATE®1

Mean Factor VIII Activity Profile After a Single Dose (50 IU/kg) in Adults (n=28)2

Eloctate stays in circulation 1.5x longer than Advate, 19.7 hours mean terminal half‐life Eloctate stays in circulation 1.5x longer than Advate, 19.7 hours mean terminal half‐life
  • 16.4-hour mean terminal half-life for adolescents1
  • 12.7-hour mean terminal half-life for patients 1 to 5 years old1
  • 14.9-hour mean terminal half-life for patients 6 to 11 years old1

Other PK parameters

  • In A-LONG, the PK profile of 28 patients on ELOCTATE obtained at Week 14 was comparable with its PK profile obtained after the first dose1
  • Additionally, FVIII activity reached its maximum level (Cmax) within an hour of ELOCTATE administration3*

*As demonstrated in a phase 1/2a study of adults with hemophilia A.

Fc=fragment crystallizable; FVIII=factor VIII; PK=pharmacokinetic.

With Fc Fusion, ELOCTATE stays in circulation 1.5x longer than ADVATE®1

Mean Factor VIII Profile After a Single Dose (50 IU/kg) in Adults (n=28)2

Mean Factor Chart_revised_ArtboardMean Factor Chart_revised_Artboard
circle-data
  • 16.4-hour terminal half-life for adolescents1
  • 12.7-hour terminal half-life for patients 1 to 5 years old, and 14.9 hours for patients 6 to 11 years old1
  • In A-LONG, the PK profile of 28 patients on ELOCTATE obtained at Week 14 was comparable with its PK profile obtained after the first dose1

ADVATE® [Antihemophilic Factor (Recombinant)] is a registered trademark of Baxalta Incorporated, a Takeda company.

PK=pharmacokinetic.

Fc Fusion helps ELOCTATE stay in circulation through a natural pathway and does not accumulate1,3

Learn more about the science behind Fc Fusion

ELOCTATE contains the Fc region of IgG11

IgG1 allows ELOCTATE to extend its half-life by binding to the neonatal Fc receptor1

IgG1 is a naturally occurring protein that has anti-inflammatory and immunomodulatory properties1,4,5

The molecular mechanism behind the effects achieved by ELOCTATE is not
yet fully understood, including the interaction with cellular Fc receptors that ELOCTATE
may interact with, such as on immune cells5

Poly vector 4,-d-,1-01
See more ELOCTATE bleed and joint bleed protection data

Fc Fusion helps ELOCTATE stay in circulation through a natural pathway and does not accumulate1,4

See Fc Fusion technology
in action

INDICATION
ELOCTATE is a recombinant DNA derived, antihemophilic factor indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

Limitation of Use

ELOCTATE is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
ELOCTATE is contraindicated in patients who have had life-threatening hypersensitivity reactions to ELOCTATE or its excipients.

WARNINGS AND PRECAUTIONS

  • Hypersensitivity reactions have been reported with ELOCTATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor VIII replacement products. Immediately discontinue ELOCTATE and initiate appropriate treatment if hypersensitivity reactions occur.
  • Formation of neutralizing antibodies (inhibitors) to Factor VIII has been reported following administration of ELOCTATE. Patients using ELOCTATE should be monitored for the development of Factor VIII inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.
  • Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
  • If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia, and catheter-site thrombosis should be considered.

ADVERSE REACTIONS
The most frequently occurring adverse reactions (incidence >0.5% of subjects) reported in previously treated patients (PTPs) clinical trials were arthralgia, malaise, myalgia, headache, and rash. The most frequently occurring adverse reactions (incidence ≥1.0% of subjects) reported in previously untreated patients (PUPs) clinical trials were Factor VIII inhibition, device-related thrombosis, and rash papular.

Please see full Prescribing Information.

Click here to learn more about Sanofi's commitment to fighting counterfeit drugs.

Reference: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc.

References: 1. Srivastava A et al. Haemophilia. 2013;19(1):e1-e47. 2. Mazepa MA et al. Blood. 2016;127(24):3073-3081.

References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Mahlangu J, Powell JS, Ragni MV, et al. Blood. 2014;123(3):317-325. 3. Powell JS, et al. Blood. 2012;119(13):3031-3037. 4. Shapiro A. Expert Opin Biol Ther. 2013;13(9):1287-1297.

References: 1. ELOCTATE [package insert]. Waltham, MA: Bioverativ Therapeutics Inc. 2. Data on file. Waltham, MA; Bioverativ Therapeutics Inc. 3. Mahlangu JN et al. Thromb Haemost. 2016;116:1-8. 4. Oldenburg J et al. Haemophilia. 2018;24(1):77-84. 5. Young G et al. J Thromb Haemost. 2015;13:1-11. 6. Nolan B et al. Haemophilia. 2016;22:72-80.

Back to the top